Quality Assurance Specialist, On the floor (Overnights)
Regeneron
August 20, 2026
On-site
East Greenbush, NY
Operations
Responsibilities:
- Support or potentially lead efforts to establish new programs for drug product facility start-up (formulation, filling, inspection, assembly, pack and label).
- Assess existing procedures/documents for suitability; establish procedures when documentation is inadequate.
- Develop, write, review, and approve SOPs, specifications, and other documents (operations/facility SOPs, quality training, batch documentation, etc.).
- Maintain project timelines; perform on-the-floor quality reviews of equipment logs, training records, testing results, batch records, and supporting documents.
- Review/approve documents (electronic and paper-based).
- Provide mentorship during on-the-floor manufacturing.
- Support audits, inspections, and investigations.
- Perform quarantine/segregation of material and line clearances.
- Contribute to continuous improvement; adjust schedules based on facility start-up, filling, and manufacturing needs.
- Collaborate with cross-functional internal teams.
Qualifications:
- B.S. in life sciences or related field (may substitute proven experience).
- Associate QA Specialist: 2+ years of experience.
- QA Specialist: 4+ years of experience (level determined by experience).
Benefits:
- Student loan paydown program & tuition reimbursement; Family Care Benefits; Relocation assistance; inclusion, culture and well-being programs (physical & mental health).
Application Instructions:
- Apply now.
- Support or potentially lead efforts to establish new programs for drug product facility start-up (formulation, filling, inspection, assembly, pack and label).
- Assess existing procedures/documents for suitability; establish procedures when documentation is inadequate.
- Develop, write, review, and approve SOPs, specifications, and other documents (operations/facility SOPs, quality training, batch documentation, etc.).
- Maintain project timelines; perform on-the-floor quality reviews of equipment logs, training records, testing results, batch records, and supporting documents.
- Review/approve documents (electronic and paper-based).
- Provide mentorship during on-the-floor manufacturing.
- Support audits, inspections, and investigations.
- Perform quarantine/segregation of material and line clearances.
- Contribute to continuous improvement; adjust schedules based on facility start-up, filling, and manufacturing needs.
- Collaborate with cross-functional internal teams.
Qualifications:
- B.S. in life sciences or related field (may substitute proven experience).
- Associate QA Specialist: 2+ years of experience.
- QA Specialist: 4+ years of experience (level determined by experience).
Benefits:
- Student loan paydown program & tuition reimbursement; Family Care Benefits; Relocation assistance; inclusion, culture and well-being programs (physical & mental health).
Application Instructions:
- Apply now.